The effect of generic market entry on antibiotic prescriptions in the United States

Acknowledgements C.K. and C.Å. were funded by the DRIVE-AB Consortium. DRIVE-AB is supported by the IMI Joint Undertaking under the DRIVE-AB grant agreement number 115618, the resources of which are composed of financial contributions from the European Union’s Seventh Framework Programme and the European Federation of Pharmaceutical Industries and Associations companies’ in-kind contribution. C.K. and C.Å. were partly supported by the Research Council of Norway through the Global Health and Vaccination Programme (GLOBVAC), project number 234608. K.O. is supported by NOA 06-IDSET160030 from the Biomedical Advanced Research and Development Authority (BARDA) under the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services, and the CARB-X award from the Wellcome Trust, but the views expressed herein are not necessarily those of CARB-X or any CARB-X funder. J.H. works for Health Services Research Unit, University of Aberdeen, and is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. R.L. was supported by 16IPA16092427 from the US Centers for Disease Control and Prevention. The funder provided support in the form of salaries for authors, according to the statement above, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.Peer reviewedPublisher PD

Introduction and Geographic Availability of New Antibiotics Approved Between 1999 and 2014

Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014

Antibiotikaresistens – kunnskapshull, utfordringer og aktuelle tiltak

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Physiotherapy alone or in combination with corticosteroid injection for acute lateral epicondylitis in general practice: A protocol for a randomised, placebo-controlled study

<p>Abstract</p> <p>Background</p> <p>Lateral epicondylitis is a painful condition responsible for loss of function and sick leave for long periods of time. In many countries, the treatment guidelines recommend a wait-and-see policy, reflecting that no conclusions on the best treatment can be drawn from the available research, published studies and meta-analyses.</p> <p>Methods/Design</p> <p>Randomized double blind controlled clinical trial in a primary care setting. While earlier trials have either compared corticosteroid injections to physical therapy or to naproxen orally, we will compare the clinical effect of physiotherapy alone or physiotherapy combined with corticosteroid injection in the initial treatment of acute tennis elbow. Patients seeing their general practitioner with lateral elbow pain of recent onset will be randomised to one of three interventions: 1: physiotherapy, corticosteroid injection and naproxen or 2: physiotherapy, placebo injection and naproxen or 3: wait and see treatment with naproxen alone. Treatment and assessments are done by two different doctors, and the contents of the injection is unknown to both the treating doctor and patient. The primary outcome measure is the patient's evaluation of improvement after 6, 12, 26 and 52 weeks. Secondary outcome measures are pain, function and severity of main complaint, pain-free grip strength, maximal grip strength, pressure-pain threshold, the patient's satisfaction with the treatment and duration of sick leave.</p> <p>Conclusion</p> <p>This article describes a randomized, double blind, controlled clinical trial with a one year follow up to investigate the effects of adding steroid injections to physiotherapy in acute lateral epicondylitis.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov Identifier: NCT00826462</p

General practitioners and tutors' experiences with peer group academic detailing: a qualitative study

<p>Abstract</p> <p>Background</p> <p>The Prescription Peer Academic Detailing (Rx-PAD) project is an educational intervention study aiming at improving GPs' competence in pharmacotherapy. GPs in CME peer groups were randomised to receive a tailored intervention, either to support a safer prescription practice for elderly patients or to improve prescribing of antibiotics to patients with respiratory tract infections. The project was based on the principles of peer group academic detailing, incorporating individual feedback on GPs' prescription patterns. We did a study to explore GPs and tutors' experiences with peer group academic detailing, and to explore GPs' reasons for deviating from recommended prescribing practice.</p> <p>Methods</p> <p>Data was collected through nine focus group interviews with a total of 39 GPs and 20 tutors. Transcripts from the interviews were analyzed by two researchers according to a procedure for thematic content analysis.</p> <p>Results</p> <p>A shared understanding of the complex decision-making involved in prescribing in general practice was reported by both GPs and tutors as essential for an open discussion in the CME groups. Tutors experienced that CME groups differed regarding structure and atmosphere, and in some groups it was a challenge to run the scheme as planned. Individual feedback motivated GPs to reflect on and to improve their prescribing practice, though feedback reports could cause distress if the prescribing practice was unfavourable. Explanations for inappropriate prescriptions were lack of knowledge, factors associated with patients, the GP's background, the practice, and other health professionals or health care facilities.</p> <p>Conclusions</p> <p>GPs and tutors experienced peer group academic detailing as a suitable method to discuss and learn more about pharmacotherapy. An important outcome for GPs was being more reflective about their prescriptions. Disclosure of inappropriate prescribing can cause distress in some doctors, and tutors must be prepared to recognise and manage such reactions.</p

Use and feasibility of delayed prescribing for respiratory tract infections: A questionnaire survey

<p>Abstract</p> <p>Background</p> <p>Delayed prescribing of antibiotics for respiratory tract infections (RTIs) lowers the amount of antibiotics consumed. Several national treatment guidelines on RTIs recommend the strategy. When advocating treatment innovations, the feasibility and credibility of the innovation must be taken into account. The objective of this study was to explore GPs use and patients uptake of wait-and-see prescriptions for RTIs, and to investigate the feasibility of the strategy from GPs' and patients' perspectives.</p> <p>Methods</p> <p>Questionnaire survey among Norwegian GPs issuing and patients receiving a wait-and-see-prescription for RTIs. Patients reported symptoms, confidence and antibiotics consumption, GPs reported diagnoses, reason for issuing a wait-and-see-prescription and their opinion about the method.</p> <p>Results</p> <p>304 response pairs from consultations with 49 GPs were received. The patient response rate was 80%. The most common diagnosis for the GPs to issue a wait-and-see prescription was sinusitis (33%) and otitis (21%). 46% of the patients reported to consume the antibiotics. When adjusted for other factors, the diagnosis did not predict antibiotic consumption, but both being 16 years or more (p = 0,006) and reporting to have a fever (p = 0,012) doubled the odds of antibiotic consumption, while feeling very ill more than quadrupled the odds (p = 0,002). In 210 cases (69%), the GP found delayed prescribing a very reasonable strategy, and 270 patients (89%) would prefer to receive a wait-and-see prescription in a similar situation in the future. The GPs found delayed prescribing very reasonable most frequently in cases of sinusitis (79%, p = 0,007) and least frequently in cases of lower RTIs (49%, p = 0,002).</p> <p>Conclusion</p> <p>Most patients and GPs are satisfied with the delayed prescribing strategy. The patients' age, symptoms and malaise are more important than the diagnosis in predicting antibiotic consumption. The GP's view of the method as a reasonable approach depends on the patient's diagnosis. In our setting, delayed prescribing seems to be a feasible strategy, especially in cases of sinusitis and otitis. Educational efforts to promote delayed prescribing in similar settings should focus on these diagnoses.</p

Somatic health among heroin addicts before and during opioid maintenance treatment: a retrospective cohort study

<p>Abstract</p> <p>Background</p> <p>The long-term impact of opioid maintenance treatment (OMT) on morbidity and health care utilization among heroin addicts has been insufficiently studied. The objective of this study was to investigate whether health care utilization due to somatic disease decreased during OMT, and if so, whether the reduction included all kinds of diseases and whether a reduction was related to abstinence from drug use.</p> <p>Methods</p> <p>Cohort study with retrospective registration of somatic disease incidents (health problems, acute or sub-acute, or acute problems related to chronic disease, resulting in a health care contact). Medical record data were collected from hospitals, Outpatients' Departments, emergency wards and from general practitioners (GPs) and prospective data on substance use during OMT were available from 2001 onwards. The observation period was five years before and up to five years during OMT. The cohort consisted of 35 out of 40 patients who received OMT between April 1999 and January 2005 in a Norwegian district town. Statistical significance concerning changes in number of incidents and inpatient and outpatient days during OMT compared with the pre OMT period was calculated according to Wilcoxon signed rank test. Significance concerning pre/during OMT changes in disease incidents by relation to the type of health service contacts, as well as the impact of ongoing substance use during OMT on the volume of contacts, was calculated according to Pearson chi-square and Fisher's exact tests.</p> <p>Results</p> <p>278 disease incidents were registered. There was a reduction in all incidents by 35% (p = 0.004), in substance-related incidents by 62% (p < 0.001) and in injection-related incidents by 70% (p < 0.001). There was an insignificant reduction in non-fatal overdose incidents by 44% (p = 0.127) and an insignificant increase in non-substance-related incidents by 13% (p = 0.741). Inpatient and outpatient days were reduced by 76% (p = 0.003) and 46% (p = 0.060), respectively. The disease incidents were less often drug-related during OMT (p < 0.001). Patients experienced a reduction in substance-related disease incidents regardless of ongoing substance use, however there was a trend towards greater reductions in those without ongoing abuse.</p> <p>Conclusion</p> <p>Although as few as 35 patients were included, this study demonstrates a significant reduction in health care utilization due to somatic disease incidents during OMT. The reduction was most pronounced for incidents related to substance use and injection. Inpatient and outpatient days were reduced. Most probably these findings reflect somatic health improvement among heroin addicts during OMT.</p